MAUDE Adverse Event Report: STRYKER GMBH NAIL HOLDING SCREW FEMUR RETROGRADE T2 ALPHA FEMUR RETROGRADE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23533904
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "the nail adapter 2353-3903 must be damaged.It would not allow the nail to be threaded on to the assembly with the holding screw 2353-3904.There was no replacement so the surgeon implanted the nail and had to ¿free hand¿ the distal screws.We tried both nail holding screws but they weren't able to start threading in to the nail due to the nail adapter.There is no visible damage to the holding screw threads or any other part of the screw.There may be damage to the nail adapter where it connect to the nail but i don't have a second one to compare it to.The surgeon ended up bypassing the nail adapter and targeting jig and used the "freehand" technique to drill and insert the two distal screws.He was satisfied with the results.".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the returned device was found to be functional and conforming to specifications.The device inspection revealed the following: both of the returned nail holding screw were apparently in good condition as no deformation/damage could be found at any location.The threads were also in good shape.The returned nail adapter and nail holding screws were assembled with a sample nail.The assembly could be done easily with no obstruction in inserting the nail holding screw in the adapter and then attaching the nail.This could be confirmed with both of the nail holding screws.Thus, the reported issue could not be reproduced and hence could not be confirmed.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on available information, the root cause of issue is deemed to be user related.The reported issue could not be reproduced.The devices were working as intended.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "the nail adapter 2353-3903 must be damaged.It would not allow the nail to be threaded on to the assembly with the holding screw 2353-3904.There was no replacement so the surgeon implanted the nail and had to ¿free hand¿ the distal screws.We tried both nail holding screws but they weren't able to start threading in to the nail due to the nail adapter.There is no visible damage to the holding screw threads or any other part of the screw.There may be damage to the nail adapter where it connect to the nail but i don't have a second one to compare it to.The surgeon ended up bypassing the nail adapter and targeting jig and used the "freehand" technique to drill and insert the two distal screws.He was satisfied with the results.".

• Brand Name: NAIL HOLDING SCREW FEMUR RETROGRADE T2 ALPHA FEMUR RETROGRADE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19760846
• Report Number: 0009610622-2024-00712
• Device Sequence Number: 8920697
• Product Code: HSB
• UDI-Device Identifier: 07613327381825
• UDI-Public: (01)07613327381825(11)220210(10)K04E080
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K203819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 23533904
• Device Lot Number: KP475985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 16 YR
• Patient Sex: Male